FDADecember 12, 2016device

SwishTapered Implant

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

What to do

FDA enforcement status: Terminated

Brands named

implant direct sybron manufacturingimplantimplant direct

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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SwishTapered Implant — Recall Details · AllClear